Meeting Minutes for SPL Generic Sub Team Meeting February 10, 2009 1.Meeting minutes from 1/13/09 – are posted on the Wiki site – any questions, additions, etc? Previous meeting minutes were accepted and there were no questions. There were several Q’s waiting for A’s from our experts (mostly, Lonnie Smith) at this meeting.Almost all of our agenda items were of this type at the meeting.They begin with item 2 … 2.How can we electronically list export only products with foreign language labeling? The question expands to ,” if the product is only for export and the package insert and labeling materials are all in the language of the country to which it is being exported and NOT in English, how is the drug listing and content of labeling to be provided under the SPL R4 requirements?What ifWe can see no reason to write an English-language label just for the filing.” Answer: In the drug listing submission, prepare a correctly formatted SPL submission.That is: ·Put text sections where they belong using appropriate LOINCs. ·Make sure to indicate with the appropriate XML tags that this product is for export only. The text inserted is NOT validated and sections are permitted to be missing.This part of the submission is not electronically validated.It may be manually validated. Post meeting note:This question was asked at another meeting and one of our team members was kind enough to report back with the response as shown below – Quote: Drug listing must be accomplished via complete SPLr4 (XML file) submission. Marketing category is identified as ‘export product’. The COL is completed with the foreign language package insert. The SPL file would “probably not be transmitted to NIH; but the SPL submission must be complete and include the COL.” The drug listing reviewer will look at the product name and strength only in the foreign language. This means that SPLr4 files will need to be created for all export only products. In the case of a foreign language package insert, we will have to create a Content of Labeling and proof it somehow. I think this will be a huge burden/cost to industry. Perhaps, we need more discussion in your team...also, it will be interesting to see how our question to the Office of Compliance is received. Unquote 3.Fed Reg publication of 10/23/08, “Comment Request; Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing” versus the same title published in the Fed Reg on 1/8/09...what is the difference?Just a comment period date extension? Answer: There is no difference from an agency perspective.This is not a comment period extension.This is an administrative update.There is the difference in the number of hours required expected for this regulation.This has been changed from 81000 hours to 83000 hours. There is no firm statement of when the regulation will be finalized. 4.Why would industry have to complete a full SPL file to tell the FDA to delist a product (not in the electronic system)?The Agency needs to provide a more cost effective and efficient means of delisting a product not in the electronic system.Today, labeling is not required to be submitted for a delisting.If the regulations are not changing, this same approach should hold true for the electronic system. Answer: The procedure is the same for electronic and paper – send the spreadsheet identifying the products to be delisted until the new regulation go into effect on June 1st … and Lonnie Smith added the following - use this method post the effective date as well. (4a) A follow-up questioned: After we submit a delisting request, how do we know this has been completed? Answer: No indication is directly provided by the FDA in the form of a letter or email.The sponsor company needs to check the website.The sponsor may also check with the drug listing office to see what products are listed under the NDC on an annual or more frequent basis. 5.For Establishment Registration, the ‘Importer’ must be identified.Does this refer to the importer of record, not the consignee?For example, Hospira, Inc. is the importer, however, the product actually is received by the Hospira Worldwide, Inc. distribution center (consignee).Would the importer be Hospira, Inc.?Additionally, the Customs Broker is not to be provided as the importer, is it? Answer: In the case above, Hospira,Inc., should be the indicated importer.That is that the importer would be listed not the consignee or the customs broker. In terms of a foreign establishment, Lonnie Smith said:
Each company name that is the owner, consignee (where shipped) or recipient should be listed as importers for each foreign establishment on the establishment registration. Remember, the consignee is the person to whom it is shipped. A further more complex example was discussed regarding an API being imported from outside the USA. 6.When is the final guidance due to be published? Answer: No firm date, this is still unknown. 7.How long prior to June 1, 2009 should a firm submit a waiver request? Answer: No date or range given. 8.Regarding the Submission Schematic from FDA (the schematic depicting the Drug Listing process in paper, the process in electronic phase 1 and the process electronic phase 2), I would like an explanation of the documentation that will be required in the Annual Report as of June 1.It appears as though a complete SPL file is required, which includes the Content of Labeling and Drug Listing for each and every Annual Report.This is not consistent with the current regulations, where Drug Listing updates must occur in June and December, or anytime in-between, at the discretion of the registrant. Answer:This is not an FDA Schematic drawing!This was created by several members of the SPL Working Group. (8a) A followup question: How many submission have been made to the pilot/transition program? Answer: Labeler Code Requests: no answer Establishment Registrations: no answer Drug Listing: ~20 9.I hate to re-hash this again and again... but could we clarify for the R4 Initiative exactly who we MUST provide DUNs numbers for as part of our Drug Establishment.I think I understand it but there will be others from our company sitting in on this call and I’d like to make sure they understand.My agenda item would be:As part of our Drug Establishment submission, must we provide DUNs # for all of our API suppliers, Excipient suppliers, Packaging manufacturers (bottles, caps, bags)? What about colorants, resins, etc included in the bottles and caps? Answer: The FDA, specifically CDER, requires the API only.With that said, DRLS may need more than this. 10.Below is from the following fda database: http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm I looked here for the UNII number for some ingredients that were not listed on the other UNII website FDA has on the SPL website. What happens if an ingredient is still PENDING at the time we submit? Answer:For UNII codes -An email should be sent to the SPL email address stating that you are ready to submit and do not as of yet have the previously requested UNII code. The SPL team may be able to assist in the acquisition of the UNII code. 11.Lonnie’s training sessions – any more openings? Answer:There were 12 seats at the May 21, 2009 Face to Face meeting when we met.There were no other Webinar connections left.The FDA will consider opening some more connections if there is very large additional request. A new training session #6 has been added and we will send this information out to the team. 12.Duns #’s updates – speaking with D&B earlier in the day – will update the team if possible. Answer:No update available at this time. 13.AOB 14.Next meeting in 4 weeks:Tuesday, March 10, 2009. Attendees
February 10, 2009
1. Meeting minutes from 1/13/09 – are posted on the Wiki site – any questions, additions, etc?
Previous meeting minutes were accepted and there were no questions.
There were several Q’s waiting for A’s from our experts (mostly, Lonnie Smith) at this meeting. Almost all of our agenda items were of this type at the meeting. They begin with item 2 …
2. How can we electronically list export only products with foreign language labeling?
The question expands to ,” if the product is only for export and the package insert and labeling materials are all in the language of the country to which it is being exported and NOT in English, how is the drug listing and content of labeling to be provided under the SPL R4 requirements? What if We can see no reason to write an English-language label just for the filing.”
Answer: In the drug listing submission, prepare a correctly formatted SPL submission. That is:
· Put text sections where they belong using appropriate LOINCs.
· Make sure to indicate with the appropriate XML tags that this product is for export only.
The text inserted is NOT validated and sections are permitted to be missing. This part of the submission is not electronically validated. It may be manually validated.
Post meeting note: This question was asked at another meeting and one of our team members was kind enough to report back with the response as shown below –
Quote:
Drug listing must be accomplished via complete SPLr4 (XML file) submission. Marketing category is identified as ‘export product’. The COL is completed with the foreign language package insert. The SPL file would “probably not be transmitted to NIH; but the SPL submission must be complete and include the COL.” The drug listing reviewer will look at the product name and strength only in the foreign language.
This means that SPLr4 files will need to be created for all export only products. In the case of a foreign language package insert, we will have to create a Content of Labeling and proof it somehow. I think this will be a huge burden/cost to industry. Perhaps, we need more discussion in your team...also, it will be interesting to see how our question to the Office of Compliance is received.
Unquote
3. Fed Reg publication of 10/23/08, “Comment Request; Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format—Drug Establishment Registration and Drug Listing” versus the same title published in the Fed Reg on 1/8/09...what is the difference? Just a comment period date extension?
Answer: There is no difference from an agency perspective. This is not a comment period extension. This is an administrative update. There is the difference in the number of hours required expected for this regulation. This has been changed from 81000 hours to 83000 hours.
There is no firm statement of when the regulation will be finalized.
4. Why would industry have to complete a full SPL file to tell the FDA to delist a product (not in the electronic system)? The Agency needs to provide a more cost effective and efficient means of delisting a product not in the electronic system. Today, labeling is not required to be submitted for a delisting. If the regulations are not changing, this same approach should hold true for the electronic system.
Answer: The procedure is the same for electronic and paper – send the spreadsheet identifying the products to be delisted until the new regulation go into effect on June 1st … and Lonnie Smith added the following - use this method post the effective date as well.
(4a) A follow-up questioned: After we submit a delisting request, how do we know this has been completed?
Answer: No indication is directly provided by the FDA in the form of a letter or email. The sponsor company needs to check the website. The sponsor may also check with the drug listing office to see what products are listed under the NDC on an annual or more frequent basis.
5. For Establishment Registration, the ‘Importer’ must be identified. Does this refer to the importer of record, not the consignee? For example, Hospira, Inc. is the importer, however, the product actually is received by the Hospira Worldwide, Inc. distribution center (consignee). Would the importer be Hospira, Inc.? Additionally, the Customs Broker is not to be provided as the importer, is it?
Answer: In the case above, Hospira,Inc., should be the indicated importer. That is that the importer would be listed not the consignee or the customs broker.
In terms of a foreign establishment, Lonnie Smith said:
Each company name that is the owner, consignee (where shipped) or recipient should be listed as importers for each foreign establishment on the establishment registration.
Remember, the consignee is the person to whom it is shipped.
A further more complex example was discussed regarding an API being imported from outside the USA.
6. When is the final guidance due to be published?
Answer: No firm date, this is still unknown.
7. How long prior to June 1, 2009 should a firm submit a waiver request?
Answer: No date or range given.
8. Regarding the Submission Schematic from FDA (the schematic depicting the Drug Listing process in paper, the process in electronic phase 1 and the process electronic phase 2), I would like an explanation of the documentation that will be required in the Annual Report as of June 1. It appears as though a complete SPL file is required, which includes the Content of Labeling and Drug Listing for each and every Annual Report. This is not consistent with the current regulations, where Drug Listing updates must occur in June and December, or anytime in-between, at the discretion of the registrant.
Answer: This is not an FDA Schematic drawing! This was created by several members of the SPL Working Group.
(8a) A followup question: How many submission have been made to the pilot/transition program?
Answer:
Labeler Code Requests: no answer
Establishment Registrations: no answer
Drug Listing: ~20
9. I hate to re-hash this again and again... but could we clarify for the R4 Initiative exactly who we MUST provide DUNs numbers for as part of our Drug Establishment. I think I understand it but there will be others from our company sitting in on this call and I’d like to make sure they understand. My agenda item would be: As part of our Drug Establishment submission, must we provide DUNs # for all of our API suppliers, Excipient suppliers, Packaging manufacturers (bottles, caps, bags)? What about colorants, resins, etc included in the bottles and caps?
Answer: The FDA, specifically CDER, requires the API only. With that said, DRLS may need more than this.
10. Below is from the following fda database:
http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
I looked here for the UNII number for some ingredients that were not listed on the other UNII website FDA has on the SPL website.
What happens if an ingredient is still PENDING at the time we submit?
Answer: For UNII codes - An email should be sent to the SPL email address stating that you are ready to submit and do not as of yet have the previously requested UNII code. The SPL team may be able to assist in the acquisition of the UNII code.
11. Lonnie’s training sessions – any more openings?
Answer: There were 12 seats at the May 21, 2009 Face to Face meeting when we met. There were no other Webinar connections left. The FDA will consider opening some more connections if there is very large additional request.
A new training session #6 has been added and we will send this information out to the team.
12. Duns #’s updates – speaking with D&B earlier in the day – will update the team if possible.
Answer: No update available at this time.
13. AOB
14. Next meeting in 4 weeks: Tuesday, March 10, 2009.
Attendees